Implants, tools, and methods for treatment of pelvic conditions

ABSTRACT

Described are various embodiments of surgical procedures, systems, implants, devices, tools, and methods, useful for treating pelvic conditions in a male or female, the pelvic conditions including incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.), vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), and other conditions caused by muscle and ligament weakness, the devices and tools including devices and tools for anchoring an implant to supportive tissue and adjusting the implant.

PRIORITY CLAIM

The present non-provisional patent Application claims priority under 35 USC §119(e) from U.S. Provisional Patent Application Ser. No. 61/468,069, filed Mar. 28, 2011, entitled “IMPLANTS, TOOLS, AND METHODS FOR TREATMENTS OF PELVIC CONDITIONS,” the entirety of which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to implants, tools, devices, systems, and related methods for treating pelvic conditions including but not limited to incontinence and prolapse conditions in men and women.

BACKGROUND

Pelvic health for men and women is a medical area of increasing importance, at least in part due to an aging population. Examples of common pelvic ailments include incontinence (e.g., fecal and urinary), pelvic tissue prolapse (e.g., female vaginal prolapse), and conditions of the pelvic floor.

Urinary incontinence can further be classified as including different types, such as stress urinary incontinence (SUI), urge urinary incontinence, mixed urinary incontinence, among others. Other pelvic floor disorders include cystocele, rectocele, enterocele, and prolapse such as anal, uterine and vaginal vault prolapse. A cystocele is a hernia of the bladder, usually into the vagina and introitus. Pelvic disorders such as these can result from weakness or damage to normal pelvic support systems.

Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUI) generally occurs when the patient is physically stressed.

In its severest forms, vaginal vault prolapse can result in the distension of the vaginal apex outside of the vagina. An enterocele is a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. Vaginal vault prolapse and enterocele represent challenging forms of pelvic disorders for surgeons. These procedures often involve lengthy surgical procedure times.

The tension of an implant (i.e., “sling”) is typically adjusted during an implantation procedure in a manner to take up slack in the sling and impart desirable and efficacious tension and positioning of the implanted sling and the supported tissue. New and improved methods of intra-operative adjusting mechanisms are always desirable.

SUMMARY

Devices, systems, and methods as described can be applied to treat pelvic conditions such as incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.), vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), levator defects, and other conditions caused by muscle and ligament weakness, hysterectomies, and the like.

Various surgical implants, tools, and methods that relate to useful or advantageous surgical procedures are described herein. Certain embodiments of method and implants involve an implant that includes an adjusting mechanism to adjust a length of an implant (e.g., a length of an extension portion or other portion or piece of an implant), intra-operatively.

Described devices and methods involve pelvic implants, including surgical implants (also referred to generally herein as “slings”) that include a central support portion and two or more end portions extending from the central support portion to sling ends. Herein, the terms “sling,” “implant,” and “incontinence sling” without further qualification are used interchangeably to include various forms of pelvic implants for supporting different pelvic tissues, and specifically include urethral slings adapted to be placed through a tissue pathway in a male or female patient, disposing the central support portion below the urethra or bladder neck (hereafter collectively referred to as the urethra for convenience) (and above the vaginal wall in a female patient) to alleviate urinary incontinence, and fecal slings adapted to be placed through a tissue pathway disposing the central support portion inferior to the anus, the anal sphincter, or the lower rectum (hereafter collectively referred to as the anus for convenience) to alleviate fecal incontinence.

In accordance with the present description, such slings include features that enhance intra-operative adjustment of the tension applied to the urethra, anus, or other supported tissue, to enhance efficacy of the implant and method of treatment, and for improved patient comfort. Various specific embodiments of the implants and methods are described herein. The various embodiments are applicable to both male and female patients to address issues of incontinence in both, to address issues of prolapse repair in female patients, and to address perineal floor descent and fecal incontinence in both. Also, surgical techniques such as forming suprapubic, retropubic, transobturator, “inside-out,” and “outside-in” tissue pathways between two skin incisions, or a tissue pathway formed from a single incision through the vagina or perineal floor (in male or female patients) are also contemplated for placement of a sling.

In various embodiments, sling tension adjustment mechanisms can be placed on one or two extension portions of an implant at locations at which the mechanisms can be accessed intra-operatively. Various designs can be useful to decrease or increase a length of an implant or extension portion, or to increase or decrease an amount of tension in an implant or extension portion. Optionally and preferably an implant can include two adjusting mechanisms at opposing locations of an implant. The two adjusting mechanisms can be actuated in coordination, meaning that the tension or length of both of the two opposing extension portions are adjusted together. Such coordinated use of two adjusting mechanisms can advantageously allow a surgeon or other user to adjust the placement, length, or tension of an implant in a manner that does not cause a urethra or other tissue to become located at a non-anatomical position relative to a midline of the patient. Stated differently, two opposing adjusting mechanisms can be adjusted together to prevent the urethra or other supported tissue from being moved in a left or a right direction within the patient, which will maintain a correct anatomical position of the urethra or other supported tissue, e.g., at a midline of the patient.

In one aspect the invention relates to a combination that includes a pelvic implant and an adjusting tool, the combination being useful to treat a pelvic condition. The implant includes a tissue support portion, a first extension portion, a second extension portion, an adjusting mechanism located on the first extension portion and capable of being actuated to adjust a length of the first extension portion, a self-fixating tip at a distal end of the first extension portion, and a self-fixating tip at a distal end of the second extension portion. The adjusting tool includes a distal end capable of engaging at least one of the self-fixating tips to allow the adjusting tool to insert the at least one self-fixating tip through a patient incision and into supportive tissue of a pelvic region. The adjusting tool also includes a distal end capable of engaging the adjusting mechanism and actuating the adjusting mechanism to adjust a length of the first extension portion.

In another aspect the invention relates to a method of treating a pelvic condition. The method includes: providing an implant that includes a tissue support portion, a first extension portion, a second extension portion, an adjusting mechanism located on the first extension portion and capable of being actuated to adjust a length of the first extension portion, a self-fixating tip at a distal end of the first extension portion, and a self-fixating tip at a distal end of the second extension portion; providing an adjusting tool that includes a distal end capable of engaging at least one of the self-fixating tips to allow the adjusting tool to insert the at least one self-fixating tip through a patient incision and into supportive tissue of a pelvic region, the distal end also capable of engaging the adjusting mechanism and actuating the adjusting mechanism to adjust a length of the first extension portion; placing the implant in a patient to support tissue; using the adjusting tool to engage a self-fixating tip and place the self-fixating tip at supportive tissue of the patient; and using the adjusting tool to actuate the adjusting mechanism to adjust a length of the first extension portion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an exemplary system or combination as described, including an embodiment of an implant and an optional insertion and adjusting tool.

FIGS. 2 and 3 show placement of implants and selected anatomy.

FIGS. 4A, 4B, 5A, 5B, 6A and 6C show exemplary devices as described.

All drawings are not to scale.

DETAILED DESCRIPTION

Pelvic floor disorders include urinary and fecal incontinence, prolapse, cystocele, rectocele, enterocele, uterine and vaginal vault prolapse, levator defects, and others, in male and female patients. These disorders typically result from weakness or damage to normal pelvic support systems. Common etiologies include childbearing, removal of the uterus, connective tissue defects, prolonged heavy physical labor and postmenopausal atrophy.

Vaginal vault prolapse is the distension of the vaginal apex, in some cases to an orientation outside of the vagina. An enterocele is a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. Vaginal vault prolapse and enterocele represent challenging forms of pelvic disorders for surgeons.

Vaginal vault prolapse is often associated with a rectocele, cystocele, or enterocele. It is known to repair vaginal vault prolapse by suturing to the supraspinous ligament or to attach the vaginal vault through mesh or fascia to the sacrum. Many patients suffering from vaginal vault prolapse also require a surgical procedure to correct stress urinary incontinence that is either symptomatic or latent.

Sling procedures for treating urinary incontinence include surgical methods that place a supportive implant such as a sling to stabilize or support the bladder neck or urethra. Various different supportive implants and sling procedures are known. Slings and methods can differ based on the type of sling material and anchoring methods used, and placement and technique for placing and supporting the sling, including tissue to be supported. In some cases, a sling is placed under the bladder neck and secured via suspension sutures to a point of attachment (e.g. bone) through an abdominal or vaginal incision. Other techniques place a supportive portion of a sling below a urethra or bladder neck, and support the sling by placement of ends at or through obturator foramen tissue. Examples of sling procedures are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534 and 6,110,101.

As used herein the terms “anchor,” “tissue fastener,” and “self-fixating tip,” refer interchangeably and non-specifically to any structure that can connect an implant to supportive tissue of a pelvic region. The supportive tissue may preferably be a soft tissue such as a muscle, fascia, ligament, tendon, or the like. The anchor may be any known or future-developed structure useful to connect an implant to such tissue, including but not limited to a clamp, a suture, a soft tissue anchor such as a self-fixating tip, and the like.

An implant can include a tissue support portion (or “support portion”) that can be used to support a urethra (including a bladder neck), bladder, vagina, levator, rectum, sphincter, or other pelvic tissue. Supporting a “urethra” refers to supporting tissue that includes the urethra (which can refer to the bladder neck), and that can optionally include tissue adjacent to a urethra such as bulbospongiosus muscle, corpus spongiosum, or both. According to specific methods involving treatment of urinary incontinence, a support portion may be placed below bulbospongiosus muscle to support both bulbospongiosus muscle and corpus spongiosum (along with the urethra), or alternately bulbospongiosus muscle may be dissected and a support portion may be placed to contact corpus spongiosum tissue (to support the urethra).

An implant can additionally include one or more extension portion (otherwise known as an “end” portion or “arm”) attached or attachable to the tissue support portion. Normally for treating incontinence an implant can include two opposing extension portions. Extension portions are elongate pieces of material (e.g., mesh, molded implant material, suture, or biologic material) that extend from the tissue support portion and are connected to the tissue support portion, and are useful to attach to supportive tissue in the pelvic region (e.g., using an anchor such as a self-fixating tip or another form of tissue fastener) to thereby provide support for the tissue support portion and the supported tissue. Generally for treating incontinence, two extension portions can extend from opposite ends of a tissue support portion as elongate “ends,” “arms,” or “extensions,” and may attach to supportive tissue in the pelvic region by extending through a tissue path to an internal anchoring point (see, e.g., Applicant's copending United States Patent Application Publication number US 2010/256442, filed Aug. 8, 2008, by Ogdahl, entitled SURGICAL ARTICLES AND METHODS FOR TREATING PELVIC CONDITIONS, the entirety of which is incorporated herein by reference), or may extend to an external incision, such as through an obturator foramen and through an external incision at a groin or inner thigh (see, e.g., Applicant's copending United States Patent Publication Number US 2006/0287571, the entirety of which is incorporated herein by reference). Also see U.S. Patent Publication number US 2011/0034759 and WO 2010/093421, PCT/US2010/057879, filed Nov. 23, 2010, and PCT/US2010/059739, filed Dec. 9, 2010, the entireties of which are incorporated hereby by reference.

In exemplary uses, each extension portion can extend from the location of attachment with the tissue support portion of the implant, through pelvic tissue, and to a location of supportive tissue within the pelvic region. The supportive tissue can be at an end of a tissue path used to perform a desired implant procedure, such as at a location near an external incision in the skin used to perform the procedure, e.g., at a location at or near an end of an extension portion placed according to a retropubic procedure or a transobturator procedure for placing a sling for treating urinary or fecal incontinence, at tissue of an obturator foramen or rectus fascia, at a ligament such as a sacrospinous ligament, etc.

An implant may include portions, pieces, or sections that are synthetic or of biologic material (e.g., porcine, cadaveric, etc.). Extension portions may be, e.g., a synthetic mesh such as a polypropylene mesh, a suture, a biodegradable suture, a molded implant material, or the like. The tissue support portion may be synthetic (e.g., a polypropylene mesh or a molded material) or biologic. Examples of implant products that may be similar to those useful according to the present description include those sold commercially by American Medical Systems, Inc., of Minnetonka Minn., under the trade names Apogee®, Perigee®, and Elevate® for use in treating pelvic prolapse (including vaginal vault prolapse, cystocele, enterocele, etc.), and Sparc®, Bioarc®, Monarc®, MiniArc®, InVance™, and AdVance™ for treating urinary incontinence.

An example of a particular type of pelvic implant is the type that includes supportive portions including or consisting of a tissue support portion and two or four extension portions extending from the tissue support portion. An implant that has exactly two or four extension portions can be of the type useful for treating urinary incontinence or vaginal prolapse. The term “supportive portions” refers to portions of an implant that function to support tissue after the implant has been implanted and specifically includes extension portions and tissue support portions, and does not include optional or appurtenant features of an implant such as a sheath, tensioning suture, tissue fastener, or self-fixating tip or other type of connector for attaching the implant to an insertion tool.

Dimensions of a tissue support portion can be any dimensions useful to support a specific tissue, e.g., urethral or vaginal tissue, for treating a pelvic condition such as incontinence, prolapse, or another pelvic condition. A tissue support portion for use in treating incontinence can be of sufficient length to support and optionally partially surround a urethra or urethra-supporting tissue. A width of a tissue support portion may optionally and preferably be greater than a width of extension portions and can be sufficiently wide to increase contact area and frictional forces between a tissue support portion and a tissue in contact with the tissue support portion. Exemplary lengths of a tissue support portion can be in the range from 0.5 to 2 inches, such as from 0.75 to 1.5 inches. Exemplary widths of a tissue support portion can be in the range from 0.4 or 0.5 to 4 centimeters, such as from 1 to 2.5 or 3 centimeters.

An implant (e.g., sling) for placement against a corpus spongiosum for treatment of urinary incontinence in a male patient may optionally and preferably include a widened central support to provide increased contact and frictional engagement with the corpus spongiosum. See, for example, Assignee's copending United States Patent Publication Number US 2006/0287571 and U.S. Pat. No. 7,422,557, the entireties of these applications being incorporated herein by reference.

Dimensions of extension portions can allow the extension portion to reach between a tissue support portion placed to support a pelvic tissue such as tissue of a urethra, vagina, anal sphincter, levator, etc. (at an end of the extension portion connected to the tissue support portion) and a location at which the distal end of the extension portion attaches to supportive tissue at or about the pelvic region. Exemplary lengths of an extension portion for use in treating incontinence by placing ends of an extension portion at tissue of an obturator foramen, for example, measured between a connection or boundary between the extension portion and the tissue support portion and a distal end of the extension portion, can be, e.g., from 0.5 to 2.5 inches, preferably from 0.5 to 1.5 inches. These or other lengths will be useful for implants designed to treat other conditions.

Implants as described can include a tissue fastener at a distal end or a distal portion of an extension portion, which is the end or portion not attached to a tissue support portion. (The term “distal” as used in this context generally refers to location at an end of an extension portion away from a tissue support portion.) A tissue fastener at a distal end or portion of an extension portion can be any of various types, including: a self-fixating tip that is inserted into soft tissue and frictionally retained; soft tissue anchors; biologic adhesive; a soft tissue clamp that can generally include opposing, optionally biased, jaws that close to grab tissue; and opposing male and female connector elements that engage to secure an end of an extension portion to tissue. (See International Patent Application No. PCT/US2007/014120, entitled “Surgical Implants, Tools, and Methods for Treating Pelvic Conditions, filed Jun. 15, 2007; U.S. patent application Ser. No. 12/223,846, filed Aug. 8, 2008, entitled SURGICAL ARTICLES AND METHODS FOR TREATING PELVIC CONDITIONS; U.S. patent application Ser. No. 12/669,099, filed Jan. 14, 2010, entitled PELVIC FLOOR TREATMENTS AND RELAYED TOOLS AND IMPLANTS; and WO 2009/075800, the entireties of which are incorporated herein by reference.) An implant may also have one or more extension portion that does not include a tissue fastener, for example if the distal end is designed to be secured to tissue by other methods (e.g., suturing), or is intended to pass through an obturator foramen and a tissue path around a pubic ramus bone, in which case the extension portion may optionally include a connector, dilator, or dilating connector, which connects to an elongate tool that can be used to either push or pull the connector, dilator, or dilating connector through a tissue path (e.g., to a medial incision).

One embodiment of a tissue fastener is a self-fixating tip. A “self-fixating tip” in general can be a structure (sometimes referred to as a soft tissue anchor) connected at a distal end of an extension portion that can be implanted into supportive tissue (e.g., muscle, fascia, ligament, or other soft tissue) in a manner that will maintain the position of the self-fixating tip and support the attached implant. Exemplary self-fixating tips can also be designed to engage an end of an insertion tool (e.g., elongate needle, elongate tube, etc.) so the insertion tool can be used to push the self-fixating tip through and into tissue for implantation, preferably also through an incision to reach the interior of the pelvic region, e.g., at a location of an obturator foramen or other supportive tissue. The insertion tool may engage the self-fixating tip at an internal channel of the self-fixating tip, at an external location such as at an external surface of the base, at a lateral extension, or otherwise as desired, e.g., in a manner to allow the insertion tool to push the self-fixating tip through an incision in a patient and through and into supportive tissue.

Exemplary self-fixating tips can include one or more lateral extensions that allow the self-fixating tip to be inserted into soft tissue and to become effectively anchored in supportive tissue. A lateral extension may be moveable or fixed. The size of the self-fixating tip and optional lateral extensions can be useful to penetrate and become anchored into the tissue. Exemplary self-fixating tips are described in Assignee's copending international patent application PCTUS2007/004015, filed Feb. 16, 2007, titled Surgical Articles and Methods for Treating Pelvic Conditions, the entirety of which is incorporated herein by reference. Other structures may also be useful.

According to exemplary embodiments, a self-fixating tip can have structure that includes a base having a proximal base end and a distal base end. The proximal base end can be connected (directly or indirectly, such as by a connective suture) to a distal end of an extension portion. The base extends from the proximal base end to the distal base end and can optionally include an internal channel extending from the proximal base end at least partially along a length of the base toward the distal base end. The optional internal channel can be designed to interact with (i.e., engage, optionally by means of a release mechanism that can be selectively engaged and released) a distal end of an insertion tool to allow the insertion tool to be used to place the self-fixating tip at a location within pelvic tissue of the patient. A self-fixating tip can be made out of any useful material, generally including materials that can be molded or formed to a desired structure and connected to or attached to a distal end of an extension portion of an implant. Useful materials can include plastics such as polyethylene, polypropylene, and other thermoplastic or thermoformable materials, as well as metals, ceramics, and other types of biocompatible and optionally bioabsorbable or bioresorbable materials. Exemplary bioabsorbable materials include, e.g., polyglycolic acid (PGA), polylactide (PLA), copolymers of PGA and PLA.

According to various systems as described, one or more instrument, insertion tool, adjusting tool, or the like, may be incorporated or used with an implant or method as described. Examples of useful tools include those that generally include one or more (stationary or moveable) thin elongate, relatively rigid shaft or needle that extends from a handle. The handle is located at a proximal end of the device and attaches to one end (a proximal end) of a shaft.

According to some embodiments, a distal end of a shaft can be adapted to engage a portion of an implant such as a tissue fastener (e.g., a self-fixating tip), in a manner that allows the insertion tool to engage and push the tissue fastener through a tissue passage and connect the tissue fastener to supportive tissue of the pelvic region. Examples of this type of tool can be used with a self-fixating tip that includes an internal channel designed to be engaged by a distal end of an insertion tool to allow the self-fixating tip to be pushed into tissue. Other general types of insertion tools will also be useful, but may engage a self-fixating tip or other tissue fastener in an alternate manner, e.g., that does not involve an internal channel. Alternately or in addition, a distal end of a shaft can be adapted to engage an adjusting mechanism and to be useful to actuate the adjusting mechanism, intra-operatively. The distal end, which can optionally engage a tissue fastener, may also be suited to engage an adjusting mechanism and actuate the adjusting mechanism, such as by rotating. A tool that can engage both a tissue fastener and an adjusting mechanism may be advantageously more convenient to use according to described methods, relative to two separate tools. Exemplary insertion tools for treatment of incontinence and vaginal prolapse are described, e.g., in U.S. patent application Ser. Nos. 10/834,943, 10/306,179; 11/347,553; 11/398,368; 10/840,646; PCT application number 2006/028828; PCT application number 2006/0260618; WO 2010/093421, and US Patent Publication No. 2010-0256442 the entireties of these documents being incorporated herein by reference. These and similar tools can be used as presented in the referenced documents, or with modifications to provide features identified in the present description.

An insertion tool can optionally include a mechanism (a “release mechanism”) by which a tissue fastener (e.g., a self-fixating tip) can be securely and releasable engaged with a distal end of an insertion tool such that the tissue fastener can be selectively secured to the distal end mechanically, then selectively released. With a releasable engagement, a tissue fastener (e.g., self-fixating tip) can be released from the distal end by releasing the engagement (e.g., mechanical engagement) by movement of an actuator at the proximal end of the insertion tool, such as at the handle. For example, an internal channel (or external surface) of a self-fixating tip can include an engaging surface designed to engage a mechanism at a distal end of an insertion tool shaft, while the self-fixating tip is placed at, on, or over the distal end. As an example, an internal or external surface of a self-fixating tip can include a depression, ring, edge, or ledge, that can be rounded, angular, etc. A mechanical detent such as a pin, ball, spring, lever, deflector, or other surface or extension located at the distal end of the insertion tool can be moved, deflected, or extended relative to the distal end of the insertion tool to contact the surface of the self-fixating tip to securely and releasably hold the self-fixating tip at the distal end of the insertion tool and selectively prevent removal of the tip from the distal end until removal is desired. The detent (or other surface or mechanism) can be caused to extend (or retract) from the distal end of the insertion tool by actuating a trigger or other mechanism located at the proximal end (e.g., handle or a proximal location of a shaft) of the insertion tool, to secure (or release) the self-fixating tip. Upon placement of the self-fixating tip at a desired location during a surgical implantation procedure, the insertion tool operator can release the self-fixating tip by use of the trigger or other mechanism at the handle to disengage the detent and cause the tip to become loose. The insertion tool can then be removed from the tissue path and the self-fixating tip can remain in a desired implanted location.

One exemplary form of implant useful for treatment of urinary incontinence is a “mini-sling,” or “single incision sling,” (e.g., as marketed by American Medical Systems under the trade name MINIARC™). Designs described herein are also useful for female pelvic floor repair products, male incontinence, for treating prolapse (e.g., vaginal prolapse), levator defects, anal incontinence, and other pelvic conditions. Devices and methods as described can be suitable for these and similar slings in the treatment of male and female urinary and fecal incontinence and to effect pelvic floor, perineal floor, and pelvic prolapse repairs that involve a variety of surgical approaches. For example, female pelvic floor repair slings may be implanted by techniques that involve transvaginal, transobturator, suprapubic, pre-pubic, or transperineal exposures or pathways. Male urinary incontinence slings may be implanted by techniques that involve transobturator, suprapubic, or transperineal pathways. Embodiments of the described devices and methods may be useful in treating fecal incontinence, by use of a transvaginal, transobturator, suprapubic or perineal floor pathway. In fecal incontinence applications, the disclosed embodiments can be used to correct the anorectal angle in the rectum to re-establish continence in patients. The above methods can, but are not necessarily limited to, use of helical needles of the type described in U.S. Pat. No. 6,911,003 or C-shaped needles or elongate needles of the type used to perform suprapubic procedures.

Referring to FIG. 1, an exemplary embodiment of an elongated sling 10 is depicted in which features of the present description may be advantageously implemented. Sling 10, including mesh 20, may be implanted by use of any of the herein-described manners and pathways through which at least end portions of sling 10 are drawn to dispose central support portion 40 in operative relation to a urethra, bladder neck, anal sphincter, or other supported tissue. Sling 10 includes extension portions 42 and 44, two tissue fasteners 8 located at each end of the extension portions, and two adjusting mechanisms 12, one each located at a location along the length of an extension portion. The depicted exemplary sling 10 thus extends between two opposing extension portions and self-fixating tips, each extension portion having an attached adjusting mechanisms 12 that can be conveniently accessed through an incision during a surgical procedure by which sling 20 is placed to support tissue of a pelvic region.

Still referring to FIG. 1, sling 10 includes a first anchor (i.e., “self-fixating tip”) 12, a second anchor 12, a first extension portion 42, a second extension portion 44, and a “central support portion” or “tissue support portion” 40. For use in treating urinary incontinence by a single incision method, the overall dimensions of sling 10 may be 6-15 cm in length, in the range from 6 to 10, 8 to 10 centimeters in length, and 1-2 cm, more preferably 1-1.5 cm, in width (at the extension portions). For use as a single-incision sling for treating urinary incontinence, a total length dimension between opposing tissue fasteners 8 can be at least sufficient to extend from an obturator internus muscle on one side of the urethra to an obturator internus muscle on the opposite side of the urethra, with central support portion 40 placed to support tissue of a urethra. (These dimensions are for an implant designed to treat incontinence by a single incision method; dimensions can be substantially different for implants designed to treat a different conditions or for implantation by a different surgical placement method.) See FIG. 2, showing relevant pelvic anatomy including a pelvic bone and opposed obturator foramen, implant 10, and urethra 58 being supported by central support portion 40.

Self-fixating tips 8 include a base, internal channel (not shown), and from two to four lateral extensions. Self-fixating tips 8 are designed to be inserted through a central (e.g., vaginal or perineal) incision in a patient by using insertion tool 60 (see FIG. 1), which includes handle 61 at a proximal end, shaft 62, tip 64 at a distal end of shaft 62, and optional actuators 65 and 67. Shaft 62 can be designed to extend from an external location, such as at an external medial incision at a perineum or vagina of a patient, to a location of placement of a tissue fastener, such as at an obturator foramen. Optionally, shaft 62 can be designed to also reach from the external location to a location of an adjusting mechanism of an implant, with the implant installed to support tissue of a patient. Shaft 62 may be a single solid length of rigid metal or plastic. Alternately, shaft 62 may include an outer hollow sleeve and an inner (e.g., flexible) moveable shaft that can be moved either rotationally or axially to cause rotational or linear (e.g., axial) movement of tip 64, e.g., to actuate an adjustment mechanism or a releasable engagement at tip 64.

In more detail, a distal end of an insertion tool can be designed to engage and push each self-fixating tip into tissue. Optionally, the distal end of the insertion tool may also include a release mechanism useful to releasably engage the self-fixating tip, and may also optionally be designed to engage and actuate each of the two adjusting mechanisms 12 to allow the same insertion tool to be used actuate one or both of adjusting mechanisms 12 in addition to placing self-fixating tips 8 at supportive tissue using a release mechanism. Thus, an exemplary tip 64 can perform one, two, or all three of the functions of: engaging a self-fixating tip to place (push) the self-fixating tip through a tissue path and into supportive tissue; releasably engaging the self-fixating tip by use of an optional release mechanism, once placed at supportive tissue; engaging an adjusting mechanism to allow tool 60 to be used to actuate the adjusting mechanism to decrease or increase a length of an extension portion. When tool 60 is designed to include a release mechanism at tip 64, tip 64 can include a detent or other release mechanism (not shown) that is actuated at handle 61 by use of actuator (e.g., button, trigger, or the like) 65. When tool 60 is designed to include a tip 64 capable of engaging an adjusting mechanism to allow tool 60 to be used to actuate the adjusting mechanism, tip 64 can be designed to fit a receiver of the adjusting mechanism and can additionally include a movement such as a rotating tip, a lever, coil, or the like, that can be caused to move by movement of actuator (e.g., button, trigger, or the like) 67 of handle 61.

Sling 10 is designed to be implanted and then left in place chronically, and includes an elongated, rectangular (as shown at FIG. 1) braided or preferably knitted, mesh strip or simply mesh 20. Sling 10 and mesh 20 are subdivided into a central support portion 40 adapted to be placed below tissue to be supported, such as a urethra. In a female patient, support portion 40 can be placed between the urethra or bladder neck and the vaginal wall. End portions 42 and 44 extend from central support portion 40 to opposing distal ends, each of which includes a tissue fastener 8 attached thereto. Mesh 20 between tissue fasteners 8 may be continuous throughout the length of sling 10. However, it will be understood that the central support portion 40 of sling 20 may be formed of other materials such that the central support portion 40 is physically attached to the end portions 42 and 44. In certain embodiments, central support portion 40 may be formed of any tissue-compatible synthetic material or any natural biocompatible material, including but not limited to treated autologous, allograft, or xenograft tissues, porcine dermis, a tissue engineered matrix, or a combination thereof. It will be understood that implant 10 may alternately be dimensioned and shaped for treatment of male or female urinary or fecal incontinence or to effect pelvic floor, perineal floor, or pelvic prolapse repairs using a variety of surgical approaches. For example, implant 10 may include more than two end portions 42 and 44 coupled to any of a connector, dilator, or tissue fastener, and extending at a variety of angles from a particularly shaped center portion 40.

In use, implant 10 can be initially placed with approximate positioning and effect (e.g., supportive force, approximation, or both) to support selected pelvic tissue. Subsequently, lengths of opposing extension portions 42 and 44 can be adjusted by use of adjusting mechanisms 12. Each self-fixating tip S can be placed within supportive tissue such as tissues of a patient's two opposing obturator foramen while the tissue support portion of the implant supports a urethra, bladder neck, vaginal tissue, etc.

With reference to a transvaginal method of treating urinary incontinence, as shown at FIG. 2, exemplary method steps include an initial step of placing implant 10, followed by an adjustment step for adjusting one or two lengths of extension portions 42 and 44. In a first step, self-fixating tip 8 can be placed at an end of an insertion tool 60 (optionally including a release mechanism), passed through a medial incision in a patient (e.g., transvaginally), and placed securely into tissue of an obturator foramen. The second self-fixating tip 8 located on the opposite extension portion of implant 10 can be inserted into tissue of the opposite obturator foramen using the same insertion tool 60 or a second identical or similar tool 60. Optionally, each step of placing a self-fixating tip at tissue of an obturator foramen can include the use of a release mechanism capable of engaging a self-fixating tip 8 at tip 64 of insertion tool shaft 62, placing the self-fixating tip 8 at supportive tissue, releasing self-fixating tip 8 from tip 64, and withdrawing insertion tool 60 from the patient.

Still referring to FIG. 2, with opposing self-fixating tips installed at opposing obturator foramen, support portion 40 is located below urethra 58, to support urethra 58. The surgeon can asses the position, tension, or both, of implant 10, supporting urethra 58, and whether a length of extension portion 42, 44, or both, should be adjusted. If adjustment is necessary, the surgeon, using an adjusting tool (e.g., a tool 60 that is designed and equipped to be useful both as an insertion tool—optionally including a release mechanism—and as an adjusting tool), places a distal end or tip 64 of tool 60 in operative engagement with first adjusting mechanism 12L and actuates the adjusting mechanism to adjust a length of an extension portion 42. If additional adjustment is necessary, the surgeon, using the adjusting tool (e.g., tool 60), places a distal end or tip 64 of tool 60 in operative engagement with the second adjusting mechanism 12R to adjust a length of an extension portion 42.

In preferred embodiments, the two adjusting mechanisms 12L and 12R can be used in coordination, meaning that the tension or length of both of the two opposing extension portions 42 and 44 are adjusted in a coordinated manner (e.g., simultaneously or non-simultaneously but alternately and in succession). Such coordinated use of two adjusting mechanisms 12L and 12R can advantageously allow the surgeon to adjust the placement, length, or tension of implant 10 in a manner that does not cause urethra 58 (or other supported tissue) to become located at a non-anatomical position relative to a midline of the patient. Stated differently, opposing adjusting mechanisms 12L and 12R can be adjusted together (optionally but not necessarily simultaneously using two adjusting tools) to prevent urethra 58 or other supported tissue from being moved in a left or a right direction within the patient, which will maintain a correct anatomical position of the urethra or other supported tissue, e.g., at a midline of the patient.

Referring to FIG. 3, a schematic illustration of a fecal incontinence sling 10 implanted in a female (for example) patient's body for treating fecal incontinence is depicted. In this illustration, central support portion 40 extends underneath the anus or anal sphincter 67 or inferior portion of the rectum (not shown, hereafter collectively referred to as the anus 67 for convenience) to correct the anorectal angle in the patient. Adjusting mechanisms 12L and 12R are located along lengths of extension portions 42 and 44, at locations to allow intra-operative access to each adjusting mechanism 12L and 12R through a medial incision in the patient. While the illustrated embodiment shows self-fixating tips 8 placed at tissue of opposing obturator foramen, other surgical approaches can be used to place sling 10 to correct fecal incontinence, including suprapubic, transobturator, retropubic, prepubic, transperineal, and transvaginal (including a single incision approach transvaginally or transperineally).

The design, including size, shape, and mechanical mode of operation, of an adjusting mechanism can be any design that allows for the adjusting mechanism to be actuated to shorten or lengthen an extension portion intra-operatively (i.e., during the course of a surgical procedure), by use of an adjusting tool that can access and actuate the adjusting mechanism intra-operatively through the same surgical incision used to place the implant. According to certain embodiments generally, an adjusting mechanism can be located at a length of extension portion (e.g., mesh, suture, or the like), connecting to two contact locations of the extension portion, and can be actuated to cause adjustment of a length of the extension portion by changing the distance between the two contact locations. According other embodiments generally, an adjusting mechanism can be located at a distal end of an extension portion (e.g., mesh, suture, or the like) as part of a tissue fastener (e.g., self-fixating tip). The adjusting mechanism can be caused to adjust a length of the extension portion by collecting a length of the extension portion in the adjusting mechanism such as by spooling the extension portion on a roller, spool, spindle, or the like.

In either of these or other embodiments, an exemplary adjusting mechanism can be actuated to shorten or lengthen a portion of the implant or extension portion by using an adjusting tool that intra-operatively contacts and mechanically engages the adjusting mechanism. For instance, the adjusting tool can be designed to include a shaft that can be extended through an incision of a patient (preferably the same incision used to insert the implant into the pelvic region of the patient) to place a distal end of the shaft at a location of the adjusting mechanism while the implant is placed therapeutically to support pelvic tissue of a patient. The shaft can include a distal end or tip that can contact and mechanically engage a receiver, port, or other engagement or actuator of the adjusting mechanism. When engaged with the adjusting mechanism the distal end of the adjusting tool can move axially (linearly along an axis of the adjusting tool shaft), rotationally (about a longitudinal axis of the adjusting tool shaft), or otherwise, either with continuous or reciprocating movement, to move a component of the adjusting mechanism such as a screw, spring, ratchet, rod, spindle, spool, drum, lever, etc., to cause the adjusting mechanism to adjust the length of the extension portion.

FIGS. 4A and 4B show examples of an implant that includes an adjustment mechanism 12 that includes a ratchet mechanism 72 that can be actuated to reduce a length of implant extension portion 42 or 44. Adjustment mechanism 12 is located at a length of mesh 20 of an implant extension portion 42 or 44, and is connected to mesh 20 by connectors 21, which pass through or are otherwise secured to mesh 20. Ratchet mechanism 72 (shown generally) is useful to adjust a length of the mesh extension portion 42 or 44, by actuation using distal end 64 of shaft 62 of an adjusting tool (e.g., tool 60, which can also function as an insertion tool). Ratchet mechanism 72 refers generally to any useful mechanism or structure, which may be reversible or non-reversible, useful to effect an adjustment of a length of mesh 20.

Tool 60 includes shaft 62 having distal end 64 capable of engaging a surface (e.g., receiver, channel, opening, or aperture) 70 of adjusting mechanism 12, to engage and operate ratchet mechanism 72. Distal end 64 is capable of movement to operate ratchet 72 by placing distal end 64 in contact with surface (e.g., receiver) 70. With distal end 64 in contact with surface (e.g., receiver) 70, distal end 64 can be moved (e.g., rotationally, as shown by the rotational arrows at FIGS. 4A and 4B) to cause ratchet 72 to move, which in turn causes connectors 21 to move together (or apart) to reduce (or increase) length L of adjusting mechanism 12 measured between connectors 21. Reducing length L brings connectors 21 closer together (see linear arrows), creating slack in mesh 20 as shown by curve or loop 25 of mesh material 25, which in turn reduces the overall length of mesh 20 and extension portion 42 or 44.

While ratchet mechanism 72 is not shown in detail, the mechanism can include any structure useful to draw connectors 21 together by actuation using distal end 64, then optionally in a reverse manner move connectors 21 apart. For example, distal end 64 can engage surface 70 (e.g., channel, opening, or aperture) of ratchet mechanism 72, and the distal end 64 can be radially or axially (with continuous or reciprocating motion) moved to cause a component of ratchet mechanism 72 to move to reduce length L between connectors 21, drawing locations of mesh 20 together and reducing length L of mesh 20.

FIGS. 5A and 5B show another embodiment of an adjustment mechanism 12, and related method. Implant extension portion 42 or 44 includes two mesh pieces 20A and 20B connected by adjustment mechanism 12 that includes ratchet 72, generally shown. Ratchet mechanism 72 as illustrated includes wheel 77 attached to first implant piece 20B through connections 23 (one at each end of wheel 77). Wheel 77 has a surface texture or surface structure that engages opposing structure at a surface of second implant piece 20A. By rotating the wheel 77 (see arrows at FIG. 5A) attached to first piece 20B, with wheel 77 engaging a surface of second piece 20A, first piece 20B moves relative to second piece 20A. The two pieces 20A and 20B can be engaged and ratchet mechanism 72 can be activated to change and define a length of an implant between ends of the implant, or a length of extension portion 42 or 44.

Still referring to FIGS. 5A and 5B, certain other general features are similar to or the same as features of the device of FIGS. 4A and 4B, including generally adjustment mechanism 12, the utility of ratchet mechanism 72, and surface 70 capable of engaging distal end 64 of shaft 62 for actuating adjusting mechanism 12 to reduce a length of extension portion 42 or 44. Adjustment mechanism 12 is connected to mesh 20A and 20B by connectors 21, which pass through or are otherwise secured to mesh 20A and 20B. Ratchet mechanism 72 (shown generally), is useful to reduce a length of the mesh extension portion 42 or 44 by actuation using distal end 64 of shaft 62 of an adjusting tool (e.g., tool 60, which can also function as an insertion tool). With distal end 64 in contact with surface (e.g., receiver) 70, distal end 64 can be moved (e.g., rotationally, as shown by the rotational arrows at FIGS. 4A and 4B) to cause ratchet 72 to move, which in turn reduces the length (L) of adjusting mechanism 12 measured between connectors 21. Reducing length L brings connectors 21 closer together, which in turn reduces the overall length of mesh 20 and extension portion 42 or 44. Optionally, ratchet mechanism 72 may be reversible, allowing adjusting mechanism 12 to be actuated by distal end 64 to increase the length of extension portion 42 or 44.

FIGS. 6A and 6B illustrate a portion of an extension portion 42 or 44 of an implant 10 (e.g., urethral sling, or other form of implant) as described herein. Implant 10 of FIGS. 6A and 6B includes adjusting mechanism 12 incorporated into self-fixating tip 8. Self-fixating tip 8, in addition to the adjusting mechanism, also includes channel 7 for engaging a tip or distal end of an insertion tool, adjusting tool, or combination insertion and adjusting tool. As illustrated, self-fixating tip 8 also includes lateral extensions 9 for securing self-fixating tip 8 at supportive tissue.

Adjusting mechanism 12 includes a moveable spring, lever, drum, spool, roll, or other collector 11 that can move (e.g., rotate) to collect (e.g., wind or spool) a portion (length) of extension portion 42 or 44 to reduce the length of extension portion 42 or 44. The collector (here, rotating drum or spool) 11 engages an end of extension portion 42 or 44, which as illustrated is in the form of a reduced-width mesh but may alternately be a suture or other suitable elongate material that can be collected or wound at an adjusting mechanism incorporated into a self-fixating tip. Optionally and as illustrated, the end of extension portion 42 or 44 that engages a collector in the form of a rotating drum 11 can be of a width dimension that matches the width dimension of drum 11, which can be a width dimension that is smaller than a width dimension of a different portion of mesh of the implant, and smaller than a dimension of self-fixating tip 8. Winding the mesh onto drum 11 reduces the length of the extension portion 42 or 44.

Optionally, not shown in the figures, a second self-fixating tip 8 that incorporates an adjusting mechanism 12, as shown at FIGS. 6A and 6B, may be placed at an opposite end of implant 10. In use, the first and second self-fixating tips 8 can be installed (e.g., internally) at opposing sides of a patient, such as at opposing obturator foramen. Implant 10 is positioned so that a central support portion supports pelvic tissue (e.g., a urethra, bladder, vaginal tissue, or another tissue). Upon installing the two opposing self-fixating tips 8, the adjusting mechanisms 12 can be actuated using an adjusting tool (e.g., 60) having shaft 62 and distal end 64, as shown at FIG. 6B. Distal end 64 of shaft 62 includes a movement that directly or indirectly engages drum 11 (or other form of collector of adjusting mechanism 12), for example at teeth 13, to collect a length of extension portion 42 or 44 by moving, e.g., rotationally, to wind a portion of the extension portion onto drum 11 to reduce the length the extension portion 42 or 44.

The disclosed systems, their various components, structures, features, materials and methods may have a number of suitable configurations as shown and described in the previously-incorporated references. Various methods and tools for introducing, deploying, anchoring and manipulate device, implants, and the like as disclosed in the previously-incorporated references are envisioned for use with the present invention as well.

All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated, and include those references incorporated within the identified patents, patent applications and publications. 

1. A combination comprising a pelvic implant and an adjusting tool, the combination useful to treat a pelvic condition, the implant comprising a tissue support portion, a first extension portion, a second extension portion, an adjusting mechanism located on the first extension portion and capable of being actuated to adjust a length of the first extension portion, a self-fixating tip at a distal end of the first extension portion, and a self-fixating tip at a distal end of the second extension portion; and the adjusting tool comprising a distal end capable of engaging at least one of the self-fixating tips to allow the adjusting tool to insert the at least one self-fixating tip through a patient incision and into supportive tissue of a pelvic region, and the adjusting tool comprising a distal end capable of engaging the adjusting mechanism and actuating the adjusting mechanism to adjust a length of the first extension portion.
 2. A combination as recited at claim 1 comprising a second adjusting mechanism located on the second extension portion, the adjusting tool comprising a distal end capable of engaging the second adjusting mechanism.
 3. A combination as recited at claim 2 comprising supportive portions consisting of a central support portion and two extension portions.
 4. A combination as recited at claim 3, the implant having a length to allow the self-fixating tips to be placed at tissue of opposing obturator foramen of a patient, with the central support portion supporting tissue of a urethra or anus.
 5. A combination as recited at claim 1 wherein the adjusting mechanism is located along a length of the first extension portion, between the self-fixating tip and a midline of the implant.
 6. A combination as recited at claim 1 wherein the adjusting mechanism is incorporated within one of the-fixating tips.
 7. A combination as recited at claim 1 wherein with the implant placed within a patient with the self-fixating tips to at tissue of opposing obturator foramen of a patient and the central support portion supporting tissue of a urethra or anus, the adjusting tool is capable of being passed through a medial incision of the patient to engage the adjusting mechanism.
 8. A combination as recited at claim 1 wherein the adjusting mechanism comprises a spool that can collect a length of first extension portion upon actuation of the adjusting mechanism.
 9. A combination as recited at claim 1 wherein the adjusting mechanism connects to a first location of the first extension portion and to a second location of the first extension portion, and the adjusting mechanism brings the first location closer to the second location upon actuation of the adjusting mechanism.
 10. A method of treating a pelvic condition, the method comprising providing an implant comprising a tissue support portion, a first extension portion, a second extension portion, an adjusting mechanism located on the first extension portion and capable of being actuated to adjust a length of the first extension portion, a self-fixating tip at a distal end of the first extension portion, and a self-fixating tip at a distal end of the second extension portion; and providing an adjusting tool comprising a distal end capable of engaging at least one of the self-fixating tips to allow the adjusting tool to insert the at least one self-fixating tip through a patient incision and into supportive tissue of a pelvic region, the distal end also capable of engaging the adjusting mechanism and actuating the adjusting mechanism to adjust a length of the first extension portion, placing the implant in a patient to support tissue, using the adjusting tool to engage a self-fixating tip and place the self-fixating tip at supportive tissue of the patient, and using the adjusting tool to actuate the adjusting mechanism to adjust a length of the first extension portion.
 11. A method according to claim 10 wherein the implant comprises a second adjusting mechanism located on the second extension portion and the adjusting tool distal end is capable of engaging the second adjusting mechanism, the method comprising using the adjusting tool to actuate the second adjusting mechanism to adjust a length of the second extension portion.
 12. A method as recited at claim 11 comprising adjusting the length of the first extension portion and the length of the second extension portion together to prevent supported tissue from being moved in a left or a right direction within the patient.
 13. A method as recited at claim 12 wherein the pelvic condition is selected from the group consisting of fecal incontinence and urinary incontinence.
 14. A method as recited at claim 13 for treating urinary incontinence, the method comprising: creating a medial incision in the patient, placing the tissue support portion to contact tissue to support the urethra, placing a distal end of the first extension portion in a tissue path extending toward a first obturator foramen of the patient, and placing a distal end of the second extension portion in a tissue path extending toward a second obturator foramen of the patient. 